insomnia
Conditions
Interventions
JK:none
YXY:Take 1 mg of estazolam every night before bedtime
ZZC:Take ZHIZICHI decotion twice a day
Sponsors
Dongzhimen Hospital of Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Healthy Subject Criteria: Meets the World Health Organization's top 10 health standards with sound physical health mental health social adaptation and moral health. Insomnia Patient Criteria: Meets both Western medical diagnostic criteria and Traditional Chinese Medicine diagnostic criteria for insomnia of spleen-stomach heat syndrome; aged 18 to 70 years (inclusive of 18 and 70); no gender restriction; insomnia duration > 1 month; PSQI score > 7; no history of severe physical diseases mental disorders or organic brain diseases; no medication use in the past week; the subject voluntarily agrees to participate in the trial and signs an informed consent form. Western Medicine Diagnostic Criteria Healthy Subject Criteria: Based on the World Health Organizations 10 health standards: Energetic and able to cope with daily life and work stress without excessive tension. Optimistic positive attitude willing to take responsibility and not overly picky. Good at resting and sleeping well. Strong adaptability to environmental changes. Resistant to common colds and infectious diseases. Appropriate body weight well-proportioned physique and coordinated posture when standing. Bright eyes sharp reactions and no eyelid inflammation. Clean teeth no cavities no pain; normal gum color with no bleeding. Shiny hair without dandruff. Muscles and skin are elastic and walking is light and powerful. Insomnia Patient Criteria: Based on the 2017 diagnostic criteria of the Chinese Sleep Research Society a patient must exhibit at least one of the following symptoms: difficulty falling asleep difficulty maintaining sleep or early awakening. If any of these symptoms occur despite adequate sleep duration and a suitable sleep environment the individual can be diagnosed with insomnia. Traditional Chinese Medicine (TCM) Syndrome Diagnostic Criteria The diagnostic criteria for spleen-stomach heat syndrome insomnia are based on the "TCM Disease and Syndrome Diagnosis and Efficacy Criteria" issued by the National Administration of Traditional Chinese Medicine. The TCM syndrome scoring is classified into four levels according to severity: none mild moderate and severe.
Exclusion criteria
Exclusion criteria: Not meeting the inclusion criteria; secondary insomnia caused by physical or mental diseases; insomnia induced by medications or alcohol; presence of liver or kidney dysfunction cardiovascular respiratory digestive or other systemic diseases; pregnant or breastfeeding women; allergy or adverse reactions to the trial medication; individuals with myasthenia gravis or acute angle-closure glaucoma; poor compliance and inability to follow medical instructions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum neuropeptides, hormone, and neurotransmitter secretion levels;Analysis of Urinary and Fecal Microbiota; | — |
Secondary
| Measure | Time frame |
|---|---|
| electrocardiogram;Renal Function Test;Liver Function Test;Hamilton Anxiety Rating Scale;Blood Routine;Hamilton Depression Rating Scale;Symptoms of the spleen and stomach;Urinalysis;Epworth Sleepiness Scale;Pittsburgh Sleep Quality Index (PSQI);State-Trait Anxiety Questionnaire;Stool Routine Test; | — |
Countries
China
Contacts
Public ContactYue Lifeng
Dongzhimen Hospital of Beijing University of Chinese Medicine
Outcome results
None listed